mp-092
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Transtympanic Micropressure Applications as a Treatment of Ménière’s Disease

Policy Number: MP-092

Latest Review Date: August 2021

Category:  DME       

Policy Grade: Effective March 17, 2020 : Active Policy but no longer scheduled for regular literature reviews and updates

POLICY:

Transtympanic micropressure applications as a treatment of Meniere’s disease is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Meniere's disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Transtympanic pressure treatment has been proposed as an alternative treatment for Meniere disease. This treatment involves use of a handheld device (e.g., Meniett) that delivers air pressure pulses to the ear.

Meniere Disease

Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. The vertigo attacks are often unpredictable, incapacitating, and may impede activities of daily living. Therapy addresses symptoms, not the underlying pathophysiology. Although the pathophysiology of Meniere disease is not precisely known, it is thought to be related to a disturbance in the pressure-volume relationship of the endolymph within the inner ear.

Treatment

Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Persons who do not respond to these conservative measures may receive gentamicin drops in the ear, as a technique of chemical labyrinthectomy to ablate vestibular function on the affected side. No therapy is available to restore hearing loss.

There has been interest in developing a more physiologic approach to treatment by applying local pressure treatment to restore the underlying fluid homeostasis. Researchers have noted that symptoms of Meniere's disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been successfully treated in hypobaric chambers. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the inner ear, thus relieving vertigo.

Transtympanic micropressure treatment for Meniere’s disease involves use of a handheld air pressure generator (Meniett) that delivers intermittent complex pressure pulses. For this device to be used, a conventional ventilation tube is surgically placed in the eardrum. Patients then place an ear-cuff in the external ear canal and treat themselves for 3 minutes, 3 times daily. Treatment is continued for as long as patients find themselves in a period of attacks of vertigo.

KEY POINTS:

The most recent literature review was updated through August 2021.

Summary of Evidence:

For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six RCTs of positive pressure therapy have been reported, with 5 trials specifically investigating the Meniett device. A systematic reviews of 5 of these trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.

Practice Guidelines and Position Statements:

American Academy of Otolaryngology-Head and Neck surgery

In 2016, the American Academy of Otolaryngology-Head and Neck Surgery updated their position statement on the use of transtympanic micropressure: “We find that there is some medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Meniere’s disease.  Micropressure therapy is best used as a second level therapy when medical treatment has failed.  The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere’s disease.” No supporting evidence was provided.

National Institute for Clinical Excellence (NICE)

In 2012, guidance from the United Kingdom’s National Institute for Clinical Excellence (NICE) concluded that current evidence on the safety of micropressure therapy for refractory Meniere's disease is inadequate in quantity.  Although there is some evidence of efficacy, it is based on limited numbers of patients.  Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit, or research.

U.S. Preventive Services Task Force Recommendations:

Not applicable.

KEY WORDS:

Meniere’s disease, Meniett, low-pressure pulse generator, transtympanic micropressure

APPROVED BY GOVERNING BODIES:

In 1999, the Meniett® device (Medtronic Xomed, Inc., Jacksonville, Florida) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510 (k) process as a symptomatic treatment of Meniere’s disease. 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

HCPCS codes:     

A4638 Replacement battery for patient owned ear pulse generator, each
E2120  Pulse generator system for tympanic treatment of inner endolymphatic fluid

REFERENCES:

  1. American Academy of Otolaryngology-Head and Neck Surgery.  Meniere’s disease.  www.entnet.org/healthinfo/balance/meniere.cfm.
  2. American Academy of Otolaryngology – Head and Neck Surgery.  AAO-HNS position on micropressure therapy.  Available at www.entnet.org/Practice/micropressure.cfm.
  3. Gurkov R, Filipe Mingas LB, Rader T et al. Effect of transtympanic low-pressure therapy in patients with unilateral Meniere's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol 2012; 126(4):356-62.
  4. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  5. National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. 2012. Available online at: //guidance.nice.org.uk/IPG426/Guidance/pdf/English. Last accessed August, 2013.
  6. National Institute on Deafness and Other Communication disorders. Health information: Ménière’s disease. www.nidcd.nih.gov/health/balance/meniere.asp.
  7. Russo FY, Nguyen Y, De Seta D, et al. Meniett device in Meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. Feb 2017; 127(2):470-475.
  8. Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Meniere's syndrome/disease with a Meniett device: a systematic review of randomized controlled trials. Clin Otolaryngol. Jun 2015; 40(3):197-207.
  9. U.S. Food and Drug Administration. FDA 510(k) marketing clearance information for the Meniett device. Available online at www.accessdata.fda.gov/cdrhdocs /pdf/K991562.pdf.
  10. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) 510(k) approvals. www.fda.gov/cdrh/pdf/k991562.pdf.
  11. van Sonsbeek S, Pullens B, van Benthem PP. Positive pressure therapy for Meniere's disease or syndrome. Cochrane Database Syst Rev. 2015; 3:CD008419.

POLICY HISTORY:

Medical Policy Group, January 2003 (1)

Medical Policy Administration Committee, February 2003

Available for comment February 6-March 24, 2003

Medical Policy Group, September 2006 (1)

Medical Policy Group, September 2008 (1)

Medical Policy Group, September 2010 (1)

Medical Policy Administration Committee, September 2010

Medical Policy Group, October 2011 (1): Update to Key Points; no change to policy statement

Medical Policy Group, October 2012 (1): 2012 Update to Key Points and References

Medical Policy Panel, October 2013

Medical Policy Group, October 2013 (3): 2013 Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (5):  Literature search from August 2014 did not yield any updates to policy.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (6):  Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Key Points, Summary and References. No change to policy intent.

Medical Policy Panel, February 2018

Medical Policy Group, February 2018 (6): Updates to Description, Key Points and Practice Guidelines.

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (6): Updates to Key Points.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points and Governing Bodies.

Medical Policy Group, March 2020 (6): Effective March 17, 2020 : Active Policy but no longer scheduled for regular literature reviews and updates

Medical Policy Group, August 2021 (6): Updates to Key Points and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.